Steris Corporation: Medical Device Recall in 2022 - (Recall #: Z-0241-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001

Product Classification:

Class II

Date Initiated: October 17, 2022

Date Posted: November 23, 2022

Recall Number: Z-0241-2023

Event ID: 91020

Reason for Recall:

Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

Status: Terminated

Product Quantity: 5 units

Code Information:

UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002

Distribution Pattern:

US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated